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A Study to See Whether Estrogen Can Slow the Growth of Some ER Positive Breast Cancers (PRESTO)

Primary Purpose

Estrogen Receptor Positive Breast Cancer

Status

Active

Phase

Phase 2

Locations

Canada

Study Type

Interventional

Intervention

Estradiol

About this trial

This is an interventional treatment trial for Estrogen Receptor Positive Breast Cancer focused on measuring ER+ breast cancer, Luminal A, Estradiol

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Female gender
Estrogen receptor positive (ER+) breast cancer
HER2 negative breast cancer
Post-menopausal by greater than 5 years
No previous hormonal replacement therapy
Low to intermediate histologic grade
ECOG Performance status of 0 of 1
Adequate hematological, renal and hepatic function is required
Ability to take oral medication
Patient must have adequate tissue for diagnosis, biomarkers and Ki67 assays

Exclusion Criteria:

Pre-menopausal women
Locally advanced or metastatic breast cancer
Current, previous or planning for pre-operative treatment with chemotherapy, hormone therapy including corticosteroids, radiation therapy for malignancy or other condition
Known hypersensitivity or intolerance to estradiol
Ischemic changes on baseline electrocardiogram
Symptomatic but untreated cholelithiasis
History of deep vein thrombosis, pulmonary embolism, stroke, acute myocardial infarction, congestive cardiac failure, untreated hypertension or known inherited hypercoagulable disorder
Undiagnosed abnormal vaginal bleeding or prior history of endometrial cancer
Untreated metabolic disturbances (glucose > 15.0 mmol/L and triglycerides > 400 mg/dL)
Current treatment with drugs known to be moderate or strong inhibitors of inducers of isoenzyme CYP3A4
The time between study enrolment and definitive breast surgery is not sufficient for administration of at least 7 days of estradiol

Sites / Locations

Cross Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Estradiol treatment

Arm Description

Estradiol 6 mg daily for 7-14 days

Outcomes

Primary Outcome Measures

To assess changes in breast cancer proliferation after a 7-14 day trial of estradiol in newly diagnosed estrogen receptor positive post-menopausal breast cancer patients prior to surgery.

Secondary Outcome Measures

Exploratory analysis of biologic correlates with comparison to available genotyping tests

Analysis of recurrence/survival data based on initial Ki67 response to 7-14 day trial of estradiol.

Full Information

NCT ID

NCT02238808

First Posted

September 10, 2014

Last Updated

February 1, 2023

Sponsor

AHS Cancer Control Alberta

1. Study Identification

Unique Protocol Identification Number

NCT02238808

Brief Title

A Study to See Whether Estrogen Can Slow the Growth of Some ER Positive Breast Cancers

Acronym

PRESTO

Official Title

PRe-operative ESTradiOl Window of Opportunity Study in Post-Menopausal Women With Newly Diagnosed ER Positive Breast Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

August 2015 (undefined)

Primary Completion Date

July 30, 2018 (Actual)

Study Completion Date

January 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AHS Cancer Control Alberta

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Some breast cancers have estrogen receptors (ER+). The investigators know that some ER+ tumours can be cured by hormone therapy alone while other ER+ breast cancers cannot. Currently, there is no perfect way to tell these groups apart nor do the investigators know why some respond when others do not. Research findings suggest that the two types of ER+ breast cancers differ in their response to estrogen with estrogen being toxic to one type and not the other. For those tumours that find estrogen toxic, this may explain why tumours only start to grow when estrogen levels decrease after menopause. The purpose of this study is to see whether a two-week treatment of estrogen equal to pre-menopausal estrogen levels will decrease the rate at which patients' ER+ tumours grow. This will be done by comparing the growth rate in the tissue removed during standard of care surgery after patients have been treated with 7-14 days of estrogen prior to that surgery.

Detailed Description

Breast cancer is a heterogeneous disease that includes two ER+ genetic subtypes (luminal A and luminal B) that differ in their response to treatment. Results from the Women's Health Initiative Trial showed that estrogen treated hysterectomized women with no prior history of breast cancer had a significant and persistent decrease in breast cancer incidence when compared to placebo treated participants. This implies that some ER+ breast cancers are in fact growth inhibited by estrogens and are not growth promoted. The hypothesis of this study is that some ER+ breast cancers (luminal A) are actually sensitive (growth inhibited) by estrogen. Objectives: To assess changes in breast cancer proliferation after a 7-14 day trial of estradiol in newly diagnosed estrogen receptor positive post-menopausal breast cancer patients prior to surgery. Exploratory analysis of biologic correlates with comparison to available genotyping tests. This is an open-label single group assignment pilot study for safety/efficacy and exploratory biologic correlates

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Estrogen Receptor Positive Breast Cancer

Keywords

ER+ breast cancer, Luminal A, Estradiol

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

19 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Estradiol treatment

Arm Type

Experimental

Arm Description

Estradiol 6 mg daily for 7-14 days

Intervention Type

Drug

Intervention Name(s)

Estradiol

Other Intervention Name(s)

estrogen

Intervention Description

Eligible participants will take 2 mg Estradiol 3 times daily for 7-14 days pre-surgery.

Primary Outcome Measure Information:

Title

To assess changes in breast cancer proliferation after a 7-14 day trial of estradiol in newly diagnosed estrogen receptor positive post-menopausal breast cancer patients prior to surgery.

Time Frame

end of 7-14 day treatment with estradiol

Secondary Outcome Measure Information:

Title

Exploratory analysis of biologic correlates with comparison to available genotyping tests

Time Frame

end of 7-14 day treatment with estradiol

Title

Analysis of recurrence/survival data based on initial Ki67 response to 7-14 day trial of estradiol.

Time Frame

10 years

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Female gender Estrogen receptor positive (ER+) breast cancer HER2 negative breast cancer Post-menopausal by greater than 5 years No previous hormonal replacement therapy Low to intermediate histologic grade ECOG Performance status of 0 of 1 Adequate hematological, renal and hepatic function is required Ability to take oral medication Patient must have adequate tissue for diagnosis, biomarkers and Ki67 assays Exclusion Criteria: Pre-menopausal women Locally advanced or metastatic breast cancer Current, previous or planning for pre-operative treatment with chemotherapy, hormone therapy including corticosteroids, radiation therapy for malignancy or other condition Known hypersensitivity or intolerance to estradiol Ischemic changes on baseline electrocardiogram Symptomatic but untreated cholelithiasis History of deep vein thrombosis, pulmonary embolism, stroke, acute myocardial infarction, congestive cardiac failure, untreated hypertension or known inherited hypercoagulable disorder Undiagnosed abnormal vaginal bleeding or prior history of endometrial cancer Untreated metabolic disturbances (glucose > 15.0 mmol/L and triglycerides > 400 mg/dL) Current treatment with drugs known to be moderate or strong inhibitors of inducers of isoenzyme CYP3A4 The time between study enrolment and definitive breast surgery is not sufficient for administration of at least 7 days of estradiol

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Judith Hugh, MD

Organizational Affiliation

University of Alberta

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cross Cancer Institute

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T6G 1Z2

Country

Canada

12. IPD Sharing Statement

Plan to Share IPD

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A Study to See Whether Estrogen Can Slow the Growth of Some ER Positive Breast Cancers

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